Medicare Policy at the Crossroads: Addressing Artificial Intelligence and Software

The United States faces a maternal health crisis demanding urgent action. The U.S. has the worst maternal outcomes among high income nations. Our maternal mortality rates far exceed peer countries’, despite the highest per capita health care spending. Protecting mothers and improving birth outcomes provides an important opportunity for bipartisan priority leadership.

WASHINGTON—AdvaMed, the Medtech Association, the largest trade association representing medtech innovators, has long pressed for faster Medicare consideration of covering treatments using FDA-authorized breakthrough medtech. President and CEO Scott Whitaker made the following comment on a new initiative from FDA Commissioner Makary and CMS Administrator Oz on greater collaboration between the agencies to close the long gap — a median of nearly six years — between FDA authorization of breakthrough medtech and Medicare coverage. The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would “expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare,” according to FDA.

AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.

The 2026AdvaMed® Payment Policy Forum takes place May 28–29 in Washington, D.C. at Hogan Lovells Office. Registration is now open, and as always,AdvaMed® members receive preferred pricing.

WASHINGTON—AdvaMed, the MedTech Association®, today announced Melissa Torres is the new Executive Vice President of Technology and Regulatory Affairs. Torres succeeds Janet Trunzo, who retired after 30 distinguished, productive years withAdvaMed®. 

In a new video developed in partnership with Patients Rising, AdvaMed’s Peter Weems, Vice President of Imaging Government Affairs and Policy Strategy, explains why the Health Tech Investment Act is critical to expanding patient access to FDA-authorized AI-enabled medical devices.

WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Brian Blaser, president and CEO of QuidelOrtho, will serve as the next chair of the AdvaMedDx Division Board of Directors, succeeding Thierry Bernard, CEO of QIAGEN. AdvaMedDx represents more than 70 manufacturers of the innovative in vitro diagnostic (IVD) tests critical to patient care. 

WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Rich Fabian, president and CEO of FUJIFILM Sonosite, will serve as the chair of the Medical Imaging division’s board of directors. He will succeed David Pacitti, CEO of Avanos Medical and former president and head of the Americas at Siemens Healthineers, the inaugural division board chair.